KEY TAKEAWAYS
- The MonumenTAL-1 phase II trial aimed to characterize the infection profile and immune function impact of talazomab in the MonumenTAL-1 phase 1/2 study.
- The result demonstrated the promise of a new RRMM therapy with deep, durable responses, low infection rates, and potential humoral immunity recovery.
For a study, researchers aimed to characterize the infection profile and immune function impact of talazomab in the MonumenTAL-1 phase 1/2 study.
The study administered subcutaneously talquetamab at doses of 0.4 mg/kg weekly (QW) or 0.8 mg/kg every two weeks (Q2W) was employed. The study assessed infection rates, B-cell subpopulations, and IgG levels as primary outcomes.
About 339 patients receiving talquetamab either weekly (tal QW, n=143) or every two weeks (tal Q2W, n=145), with 51 having prior T-cell redirection therapy (pTCRT), the median follow-up was 15.9, 10.1, and 13.1 months, respectively. Infections of any grade occurred in 58% (22%) for tal QW, 65% (16%) for tal Q2W, and 71% (26%) for pTCRT.
Infections (grade 3/4) with concomitant grade 3/4 neutropenia were 8% (3%) for tal QW, 2% (0.7%) for tal Q2W, and 18% (2%) for pTCRT. New-onset infections were most prevalent during cycles 1–2. Grade 3/4 infections included pneumonia (3.5%) and UTI (2.1%) on tal QW; pneumonia (2.1%) and COVID-19 (2.1%) on tal Q2W; and pneumonia (5.9%) with pTCRT.
Opportunistic infections occurred in 3.5%, 4.1%, and 5.9% of patients. Less than 1.5% of patients died from infections, including COVID-19 pneumonia (n=2), and one each due to septic shock, fungal sepsis, and unknown etiology.
Hypogammaglobulinemia rates were tal QW 64.3%, tal Q2W 65.5%, and pTCRT 70.6%. Intravenous immunoglobulin (IVIG) use was 14.7%, 12.4%, and 15.7%, respectively. CD19+ B-cell levels were stable, with a trend toward increased nonclonal IgG.
The result demonstrated the promise of a new RRMM therapy with deep, durable responses, low infection rates, and potential humoral immunity recovery.
Source: https://clml-soho2023.elsevierdigitaledition.com/480/index.html
Clinical Trial: https://clinicaltrials.gov/study/NCT04634552
Rodriguez-Otero P, Schinke C, Chari A, Lipe B, Lavi N, Rasche L, Vishwamitra D, Skerget S, Verona R, Ma X, Khedkar S, Hilder B, Masterson T, Campagna M, Renaud T, Tolbert J, Heuck C, Smit MD, van de Donk N. Analysis of Infections and Parameters of Humoral Immunity in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With Talquetamab (tal) Monotherapy in MonumenTAL-1.
